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临床试验/CTRI/2024/07/070864
CTRI/2024/07/070864尚未招募2/3 期

Comparative Evaluation of Efficacy of Two Anatomically Preformed Supraglottic Airway Devices for Ventilation in Adult Patients Undergoing Elective Surgery Under General Anaesthesia

VMMC AND Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Laryngeal Mask Airway Protector will have a better clinical efficacy with that of

研究概览

简要总结

The supraglottic airway devices (SADs) have been widely used as an alternative to tracheal intubation during general anaesthesia or as an immediate life-saving measure in patients with difficult or failed airway. Since the introduction of the Classic Laryngeal Mask Airway (LMA)by Dr. Archie brain, UK, several innovative supraglottic airway devices have been developed. The second-generation SADs such as Laryngeal Mask Airway Proseal, Laryngeal Mask Airway Supreme, LMA Protector and BlockBuster LMA integrate gastric drainage tubes and improved airway seal, enhancing patient safety. LMA Protector and BlockBuster LMA can be used as conduit for blind endotracheal intubation as they may help to tackle the “cannot ventilate cannot intubate " situation and can be lifesaving in difficult airway situations. SADs with intubation conduit are also recommended by All India Difficult Airway Association guidelines 2016 for difficult airway situations. Laryngeal Mask Airway Protector (LMA-Protector) is a new second generation supraglottic device made with medical-grade silicone. The LMA Protector provides access to, and functional separation of, the ventilation and digestive tracts, with the presence of two drainage channels, which emerge proximally as separate ports and enter a chamber, located behind the cuff bowl. BlockBuster LMA. It is an anatomically curved device made up of silicone. It provides access to and functional separation of the ventilation and digestive tracts. We hypothesize that the LMA Protector will have a better clinical efficacy for ventilation as compared to BlockBuster LMA in terms of higher oropharyngeal leak pressure in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation. However, there is paucity of studies comparing the above two devices. Therefore we designed this study to evaluate and compare the LMA Protector with BlockBuster LMA for efficacy of ventilation in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation with the primary objective of comparison of oropharyngeal leak (seal) pressure between the two devices

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients between 18-60 years, weighing 30-70 kg who meet the standards of the American Society of Anesthesiologists (ASA) grade I, II, undergoing elective surgery under general anaesthesia with controlled ventilation.

排除标准

  • Patients with anticipated difficult airway.
  • Body Mass Index more than 30kg/m
  • High risk of aspiration.

结局指标

主要结局

Laryngeal Mask Airway Protector will have a better clinical efficacy with that of

时间窗: At Base line

BlockBuster Laryngeal Mask Airway in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation.

时间窗: At Base line

次要结局

  • Compare insertion characteristics of Laryngeal Mask Airway Protector with(BlockBuster Laryngeal Mask Airway)

研究者

发起方
VMMC AND Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rahul Yadav

VMMC AND Safdarjung Hospital

研究点 (1)

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